Evidence map›Paper›PMID 24906174›Full record

Trial reportJournal of hypertension2014

Effects on office and home blood pressure of the lercanidipine-enalapril combination in patients with Stage 2 hypertension: a European randomized, controlled clinical trial.

Giuseppe Mancia, Antonio Coca, Irina Chazova, Xavier Girerd, Hermann Haller, Paolo Pauletto, Danuta Pupek-Musialik, Yevgeniya Svyshchenko, FELT investigators

Erratum issuedOpen access · hybridAbstract readMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Journal of hypertension, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
2.8field-weighted citation impact, top 9% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

5 citing papers in PubMed, 24 citations in OpenAlex.

  1. New Insights into the Nephroprotective Potential of Lercanidipine.International journal of molecular sciences · 2023
    Review
  2. Observational
  3. Review
  4. Review
  5. Lercanidipine in the Management of Hypertension: An Update.Journal of pharmacology & pharmacotherapeutics
    Review
4 · The record

Corrections and comments

  • Erratum issued
5 · Who and what money

Authors and funding

9 authors at 6 institutions in 5 countries.

Giuseppe ManciaaIRCSS, Istituto Auxologico Italiano and University Milano-Bicocca, Milan, Italy bHospital Clínic of Barcelona, University of Barcelona, Barcelona, Spain cInstitute of Clinical Cardiology, Department of Systemic Hypertension, Moscow, Russia dCardiovascular Prevention Unit, Hôpital de la Pitié Salpétrière, Paris, France eHannover Medical School, Department of Nephrology and Hypertension, Hannover, Germany fDepartment of Internal Medicine, University Hospital of Treviso & University of Padova, Padova, Italy gDepartment of Biochemistry and Molecular Biology, Karol Marcinkowski University of Medical Sciences, Poznan, Poland hStrazhesko Institute of Cardiology, Kiev, Ukraine.
Antonio Coca
Irina Chazova
Xavier Girerd
Hermann Haller
Paolo Pauletto
Danuta Pupek-Musialik
Yevgeniya Svyshchenko
FELT investigators
Hospital Clínic de Barcelona · ESMedizinische Hochschule Hannover · DENational Scientific Center "M.D. Strazhesko Institute of Cardiology" · UAOspedale San Giuseppe · ITPitié-Salpêtrière Hospital · FRUniversity of Padua · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesThe aim of this study was to evaluate the efficacy and safety of combinations of lercanidipine (L) and enalapril (E) at different doses on office and home blood pressure (BP) in patients with Stage 2 hypertension. STUDY

designThis was a randomized, double-blind, placebo-controlled, factorial study conducted in 100 centres from seven countries. Patients with office DBP 100-109 mmHg and home DBP at least 85 mmHg at the end of a 2-week placebo run-in period were randomized to a 10-week treatment with placebo, L (10 or 20 mg), E (10 or 20 mg) or the four L-E combinations. The efficacy parameters were office DBP at trough (primary), SBP at trough and home SBP and DBP. Office BP was measured at each visit in both the sitting and the standing position, while home BP was measured twice in the morning and twice in the evening for at least 3 days before treatment and at study end. Safety parameters included adverse events, laboratory tests and 12-lead ECG.

resultsA total of 1039 patients were randomized (48% men, mean age 54 years, mean BMI 30 kg/m, 40% obese patients). Baseline BP was similar in all groups and lower for home than for office values (149/95 and 159/103 mmHg, respectively). A marked placebo effect was observed on office but not on home BP. Combination therapy was superior to placebo at all doses for both office and home BP. The greatest effect was observed in the L20/E20 group, in which the SBP/DBP fall amounted to -19.2/-15.2 and -13.2/-7.5 mmHg for sitting office and home BP, respectively. Similar reductions were observed on standing office BP. The L20/E20 combination was associated with less cough, palpitations and leg oedema than monotherapies, with no increased rate of dizziness or hypotension.

conclusionIn Stage 2 hypertension, a fixed-dose combination of L and E ensures a control of both office and out-of-office BP, with a favourable tolerability profile.

Indexed as

AdultAgedAngiotensin-Converting Enzyme InhibitorsBlood PressureCalcium Channel BlockersDihydropyridinesDouble-Blind MethodDrug CombinationsEnalaprilFemaleHumansHypertensionMaleMedication AdherenceMiddle AgedAngiotensin-Converting Enzyme InhibitorsCalcium Channel BlockersDihydropyridinesDrug CombinationsEnalaprillercanidipine

Identifiers

PMID24906174
PMCPMC4166043
OpenAlexW2079803938

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.